FDA-Drug2015-09-16Class II
Ropivacaine HCl 0.2% in 100 mL total volume in a 100 mL Yellow Cassette Res. Flowstop in Sodium Chloride 0.9%, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141, NDC 61553-834-48
Pharmedium Services, LLC
Hazard
Lack of Assurance of Sterility: The firm received a complaint of a sterility failure using a non-validated sterility test on a medication cassette.
Sold states
VA, IL, PA, ID
Affected count
120 cassettes
Manufactured in
150 N Field Dr Ste 350, N/A, Lake Forest, IL, United States
Products
Ropivacaine HCl 0.2% in 100 mL total volume in a 100 mL Yellow Cassette Res. Flowstop in Sodium Chloride 0.9%, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141, NDC 61553-834-48
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1428-2015Don't want to check this manually?
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